Engineer I

About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry.

Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL.

Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.  Position Summary cGMP Consulting is seeking a motivated and detail-oriented individual to support the execution of engineering activities for equipment, utilities, facilities, systems, and processes.

This entry-level role offers the opportunity to gain hands-on experience in a dynamic, GMP-compliant manufacturing environment.  The ideal candidate will excel in critical thinking, technical writing, and protocol execution while demonstrating the ability to work with limited supervision.

This candidate should have a basic understand of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.  Responsibilities  The essential functions include, but are not limited to the following :

• Assist in the setup, testing, and daily operation of new processes, equipment and systems in collaboration with Engineering teams.  Perform validation and qualification tasks for equipment, utilities, cleaning procedures, computer systems, and / or new products.  Execute validation / qualification studies for utilities, equipment, cleaning processes, computer systems, and new products, including protocol preparation and final report documentation.  Support deviation investigations by collecting data, writing reports, and performing supplemental qualification activities.  Author SOP updates and revisions related to processes, equipment and system modifications.  Operate and program instruments (e.g., temperature / humidity dataloggers) for controlled temperature / humidity chamber qualifications (e.g., lyophilizers, warehouses, sterilizers, incubators).  Collaborate with SMEs to identify and resolve technical challenges effectively.  Maintain compliance with company policies, cGMPs, regulatory requirements, and safety protocols.  Utilize tools such as Word, Excel, and electronic document management systems to complete tasks efficiently.  Perform additional tasks as assigned by management.  Requirements  Bachelors’ degree in Engineering, Science, or a related field of study.  0-2 years’ experience in a GMP manufacturing environment.  Experience in technical writing including drafting standard operating procedures, protocols, and / or reports is preferred.  Familiar with regulatory (FDA) requirements.  Business minor or coursework is strongly encouraged.  Advanced critical thinking and technical writing skills.

Strong organizational, communication, and interpersonal skills.  Compensation and Benefits  Expected pay range per year :